Description:
The purpose of this study is to use precision medicine in the form of a vaccine, a
mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care
treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).
The study is designed to determine whether this treatment combination is well tolerated and
safe.
Title
- Brief Title: Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma
- Official Title: Phase I Study of Tumor Treatment Fields and a Personalized Mutation-derived Tumor Vaccine in Patients With Newly Diagnosed Glioblastoma
Clinical Trial IDs
- ORG STUDY ID:
GCO 17-0566
- SECONDARY ID:
16-089
- NCT ID:
NCT03223103
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Poly-ICLC | Hiltonol® | Mutation-derived tumor vaccine |
Peptides | Personalized peptides | Mutation-derived tumor vaccine |
Purpose
The purpose of this study is to use precision medicine in the form of a vaccine, a
mutation-derived tumor antigen vaccine (MTA-based vaccine) in combination with standard care
treatment of glioblastoma (GBM) and Tumor Treating Fields (TTFields).
The study is designed to determine whether this treatment combination is well tolerated and
safe.
Detailed Description
This is a single-arm, single institution phase 1a / 1b study to test the safety,
tolerability, and immunogenicity of MTA-based personalized vaccine in patients with newly
diagnosed GBM along with the use of continual TTFields. MTA-based personalized vaccine is
prepared in the laboratory with several peptides based on each patient's own tumor sequence.
The vaccine is given after the radiation and chemotherapy portion of the treatment, in the
maintenance phase of temozolomide in conjunction with the TTFields.
Trial Arms
Name | Type | Description | Interventions |
---|
Mutation-derived tumor vaccine | Experimental | MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields | |
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18
- Confirmation of GBM (WHO grade IV).
- Maximal debulking surgery and undergo radiotherapy concomitant with Temozolomide
(45-70Gy)
- Stable disease after treatment of radiation with chemotherapy
- Life expectancy > 16 weeks.
- Performance status of 0-2 (Eastern Cooperative Oncology Group).
- First vaccine treatment start date at least 4 weeks out but not more than 8 weeks from
the last dose of concomitant Temozolomide or radiotherapy.
- Must have tumor tissue sufficient sequencing.
- Have adequate bone marrow function
- Require Dexamethasone ≤ 4mg daily on a stable dose
- Acceptable hematologic, hepatic, and renal function and these tests must be performed
within 14 days prior to study
- The participant must be deemed competent to give informed consent.
- The participant must agree to use two effective forms of contraception beginning at
least four (4) weeks prior to study entry.
Exclusion Criteria:
- Progression of disease at time of screening.
- Implanted pacemaker, programmable shunts, defibrillator, deep brain stimulator, other
implanted electronic devices in the brain, or documented clinically significant
arrhythmias.
- Infra-tentorial tumor or multifocal disease.
- History of hypersensitivity reaction to Temozolomide.
- Receiving any other investigational agents.
- Prior history of unrelated neoplastic disease, and having received systemic therapy
for the secondary malignancy within the twelve (12) month period preceding the
screening evaluation.
- (HIV/AIDS), Chronic hepatitis B or hepatitis C.
- History of, or is reasonably suspected to meet criteria for the diagnosis of a known
congenital or acquired disorder causing systemic immunosuppression.
- History of, or is reasonably suspected to meet criteria for the diagnosis of a
systemic auto-immune/inflammatory disease or other autoimmune disorder with the
exception of: Vitiligo
- Positive pregnancy test [45 CFR 46.203(b)].
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose-limiting toxicities (DLT) |
Time Frame: | 42 weeks |
Safety Issue: | |
Description: | Feasibility administration of one vaccine; toxicity will be measured by severity of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale |
Secondary Outcome Measures
Measure: | Toxicity grading using CTCAE scale |
Time Frame: | 1 year |
Safety Issue: | |
Description: | Safety will be measured by number of Adverse events with toxicity grading defined by Cancer Therapy Evaluation Program's (CTEP) v4.0 of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) scale |
Measure: | The percent Progression Free Survival (PFS) |
Time Frame: | 6 months |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) Rate |
Time Frame: | 1 year |
Safety Issue: | |
Description: | |
Measure: | Overall Response Rate |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Overall response as measured by RANO Response Criteria: Complete response, Partial response, Stable Disease, and Progressive Disease |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Adilia Hormigo |
Trial Keywords
- Brain cancer
- Glioblastoma
- Personalized vaccine
- Poly-ICLC
- Immunotherapy
- Cancer
- NovoTTF-200A
- Optune
- GBM
- immunogenicity
Last Updated
July 8, 2021